消癌平注射液联合培美曲塞和奥沙利铂治疗晚期肺腺癌的临床研究

Clinical study on Xiaoaiping Injection combined pemetrexed and oxaliplatin in treatment of advanced lung adenocarcinoma

目的研究消癌平注射液联合注射用培美曲塞二钠和注射用奥沙利铂治疗晚期肺腺癌的临床疗效。方法选取2014年11月—2016年11月在阜阳市第二人民医院治疗的晚期或转移性的肺腺癌患者130例,所有患者按照入组顺序编号,采用序列号随机法分为对照组和治疗组,每组各65例。对照组第1天静脉滴注注射用培美曲塞二钠500 mg/m2,滴注时间大于10 min;且第1天还静脉滴注注射用奥沙利铂,500 mg/m2加入到5%葡萄糖溶液250 mL中,滴注时间2~6 h。治疗组在对照组基础上静脉滴注消癌平注射液,40 mL加入到5%葡萄糖250 mL中,1次/d,治疗14 d。两组患者均以21 d为1个疗程,治疗2个疗程。观察两组的临床疗效,比较两组的血清肿瘤标志物和T淋巴细胞亚群的变化情况。结果治疗后,对照组和治疗组的缓解率分别为46.15%、66.15%,两组比较差异有统计学意义(P<0.05),两组总有效率比较差异无统计学意义。治疗后,对照组糖类抗原125(CA125)和癌胚抗原(CEA)水平下降,治疗组神经元特异性烯醇化酶(NSE)、CA125和CEA水平下降,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组NSE和CA125水平明显低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,对照组CD^(3+)、CD^(4+)和CD^(4+)/CD^(8+)明显降低,而治疗组CD^(3+)和CD^(4+)/CD^(8+)明显提高,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组这些观察指标明显高于对照组,两组比较差异具有统计学意义(P<0.05)。结论消癌平注射液联合注射用培美曲塞二钠和注射用奥沙利铂治疗晚期肺腺癌具有较好的临床疗效,可调节肿瘤标志物,改善T淋巴细胞亚群水平,具一定的临床推广应用价值。

Objective To study the clinical effect of Xiaoaiping Injection combined with Pemetrexed Disodium for injection and Oxaliplatin for injection in treatment of advanced lung adenocarcinoma. Methods Patients （130 cases） with advanced lung adenocarcinoma in No. 2 People＇s Hospital of Fuyang City from November 2014 to November 2016 were randomly divided into control and treatment groups, and each group had 65 cases. Patients in the control group were iv administered with Pemetrexed Disodium for injection with 500 mg/m2 at the first day of treatment, infusion time more than 10 min. And they also were iv administered with Oxaliplatin for injection at the first day of treatment, 500 mg/m2 added into 5% glucose solution 250 mL, infusion time 2 — 6 h. Patients in the treatment group were iv administered with Xiaoaiping Injection on the basis of the control group, 40 mL added into 5% glucose solution 250 mL, once daily, treated for 14 d. Patients in two groups were treated for 2 courses, 21 d as a course. After treatment, the clinical efficacies were evaluated, and tumor marker and T lymphocyte subset in two groups were compared. Results After treatment, the remission rates in the control and treatment groups were 46.15% and 66.15%, respectively, and there was difference between two groups （P 〈 0.05）. But there were no differences of clinical efficacy between two groups. After treatment, the levels of CA125 and CEA in the control group were significantly decreased, but the levels of NSE, CA125, and CEA in the treatment group were significantly decreased, and the difference was statistically significant in the same group （P 〈 0.05）. And the levels of NSE and CA125 in the treatment group were significantly lower than those in the control group, with significant difference between two groups （P 〈 0.05）. After treatment, CD3＋, CD4＋, and CD4＋/CD8＋ in the control group were significantly decreased, but CD3＋ and CD4＋/CD8＋ in the treatment group were significantly increased, and the difference was statistically significant in the same group （P 〈 0.05）. And the observational indexes in the treatment group were significantly higher than those in the control group, with significant difference between two groups （P 〈 0.05）. Conclusion Xiaoaiping Injection combined with Pemetrexed Disodium for injection and Oxaliplatin for injection has clinical curative effect in treatment of advanced lung adenocarcinoma, can regulate tumor marker, and improve T lymphocyte subset levels, which has a certain clinical application value.